Adjuvant Arthroscopy Does Not Improve the Functional Outcome of Volar Locking Plate for Distal Radius Fractures: A Randomized Clinical Trial.

PURPOSE: To evaluate the outcomes of adding arthroscopy to osteosynthesis of distal radius fractures (DRF) with volar locking plate (VLP), by Patient-Rated Wrist Evaluation (PRWE) 1 year after surgery. METHODS: In total, 186 functionally independent adult patients who met the inclusion criteria (DRF and a clinical decision for surgery with a VLP) were randomized to arthroscopic assistance or not. Primary outcome was PRWE questionnaire results 1 year after surgery. For the main variable, PRWE, we obtained the minimal clinically important difference based on a distribution-based method. Secondary outcomes included Disabilities of the Arm, Shoulder and Hand and 12-Item Short Form Health Survey questionnaires, range of motion, strength, radiographic measures, and presence of joint step-offs by computed tomography. Data were collected preoperatively and at +1 and +4 weeks, +3 and +6 months, and +1 year after surgery. Complications were recorded throughout the study. RESULTS: In total, 180 patients (mean age: 59.0 ± 14.9 years; 76% women) were analyzed by modified intention to treat. A total of 82% of the fractures were intra-articular (AO type C). No significant difference between arthroscopic (AG) and control (CG) groups in median PRWE was found at +1 year (median AG: 5.0, median CG: 7.5, difference in medians 2.5; 95% confidence interval [CI] -2.0, 7.0, P = .328). The proportion of patients who exceeded the minimal clinically important difference of 12.81 points in the AG and CG was 86.4% vs 85.1%, P = .819, respectively. Percentage of associated injuries and step-offs reduction maneuvers was greater with arthroscopy (mean differences: 17.1 95% CI -0.1, 26.1, P < .001) and 17.4 (95% CI 5.0, 29.7, P = .007). The difference in percentage of residual joint step-offs at the postsurgical computed tomography in radioulnar, radioscaphoid, and radiolunate joints was not significant (P = .990, P = .538, and P = .063). Complications were similar between groups (16.9% vs 20.9%, P = .842). CONCLUSIONS: Adjuvant arthroscopy did not significantly improve PRWE score +1 year after surgery for DRF with VLP, although the statistical power of the study is below the initially estimated to detect the expected difference. LEVEL OF EVIDENCE: Level I, randomized controlled trial.

Effect of Obesity and Roux-En-Y Gastric Surgery on Omeprazole Pharmacokinetics.

INTRODUCTION: The prevalence of obesity is increasing globally. The principal aim was to evaluate whether gastric bypass surgery modifies the bioavailability and pharmacokinetic (PK) parameters of omeprazole. METHODS: Controlled, open-label, bioavailability clinical trial in patients undergoing Roux-en-Y gastric bypass (RYGB). Healthy patients with obesity (body mass index >35) were included and assessed for omeprazole PKs before and after RYGB (1 and 6 months). PK sampling was done at baseline and several times up to 12 h after drug dosing. Pre- and post-surgery parameters were compared using paired ANOVA or Wilcoxon tests, and control versus cases using ANOVA or Mann-Whitney tests. Given the post-surgery change in body weight, parameters were corrected by dose/body weight. RESULTS: Fourteen case and 24 control subjects were recruited; 92% were women (N = 35/38). In patients who underwent RYGB, maximum plasma concentration (Cmax) was significantly reduced at 1 and 6 months after surgery compared with presurgery values (p = 0.001). Regarding the AUC, the values are lower at 1 and 6 months after surgery than at baseline (p < 0.001). The drug clearance was also increased in the first month after surgery. No differences were found between patients 6 months after surgery and controls. Cmax and AUC corrected by dose/body weight were significantly different between the baseline surgery subjects and controls. Discusion/Conclusions: Omeprazole bioavailability is reduced in patients with obesity at 1 and 6 months after RYGB. However, omeprazole PK parameters 6 months after RYGB are similar to control subjects, and thus no dose correction is required after RYGB for a given indication.

La isoapariencia farmacéutica un factor de riesgo de errores de medicación / Pharmaceutical "isoappearance": a risk factor for medication errors

OBJETIVO: conocer la opinión de los profesionales de Enfermería sobre la influencia de la isoapariencia farmacéutica en el desarrollo de errores de medicación. MÉTODO: se realizó un estudio descriptivo transversal entre abril y mayo de 2017. Los sujetos de estudio fueron profesionales de Enfermería procedentes de dos hospitales españoles de nivel terciario. Para la recolección de los datos se utilizó un cuestionario diseñado ad hoc para el estudio, que incluía 21 ítems con cinco posibles respuestas según escala Likert (1 = muy en desacuerdo a 5 = muy de acuerdo). Se realizó estadística descriptiva. Se usó del software estadístico SPSS V.22. RESULTADOS: participaron 123 profesionales de Enfermería. El 96% (n = 118) de los encuestados consideró la isoapariencia farmacéutica como un factor de riesgo para la incursión en un error de medicación. Un 15% (n = 19) de la muestra reconoció haber cometido un error por este motivo. CONCLUSIONES: la isoapariencia farmacéutica es percibida por los profesionales de Enfermería como un factor de riesgo de errores de medicación

OBJECTIVE: to understand the opinion of Nursing Professionals about the influence of pharmaceutical "isoappearance" on the occurrence of medication errors. METHOD: a descriptive cross-sectional study was conducted between April and May, 2017. The study subjects were Nursing Professionals from two Spanish tertiary hospitals. Data collection was conducted through a questionnaire designed ad hoc for the study, including 21 items with five possible answers according to the Likert Scale (1 = extremely disagree to 5 = extremely agree). Descriptive statistics analysis was conducted, using the SPSS statistical software version 22. RESULTS: the study included 124 Nursing professionals; 96% (n = 118) of the participants considered that pharmaceutical "isoappearance" was a risk factor for making medication errors, while 15% (n = 19) of the sample admitted that they had made a mistake for this reason. CONCLUSIONS: pharmaceutical "isoappearance" is perceived by Nursing professionals as a risk factor for medication errors

Integración de la tramitación del contrato de ensayo clínico en el plazo de evaluación por el Comité de Ética de Investigación Clínica. Estudio piloto MINT&R ®-cec / Integration of clinical trial agreement process in Ethics Committee evaluation timelines. Pilot study MINT&R ®-cec

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